- Device
- OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S044
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2015-12-16
- Decision code
- OK30
- Date received
- 2015-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO RELOCATE YOUR FABRIC VENDOR'S MANUFACTURING OPERATIONS TO LA COITAT, FRANCE.